K-number	DEN240077
Device name	MuReva OM
Applicant	Mureva Phototherapy, Inc.
Product code	SGQ
Device class	Class II
Decision date	Nov 26, 2025
Decision	Not Substantially Equivalent
Regulation	872.5595

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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MuReva OM

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MuReva OM